FDA.reportPublic FDA data

NDC 80425-0177-01 - Pregabalin

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
80425-0177
Requested NDC
80425-0177-01
Package NDCs from labels
80425-0177-3, 80425-0177-1, 80425-0177-2, 80425-0177-01
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2024-12-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Pregabalin - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0177-1Pregabalin30 in 1 BOTTLECAPSULE305
80425-0177-2Pregabalin60 in 1 BOTTLECAPSULE605
80425-0177-3Pregabalin90 in 1 BOTTLECAPSULE905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0177PREGABALIN CAPSULE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]5Current NDC, Legacy NDC, 3 package rows20250101_d2804923-a466-6dc6-e053-2a95a90a4182.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0177-1EA - Each80425-017744662712-df1a-4896-9249-284265b597be12023-06-06
80425-0177-2EA - Each80425-0177d1d76d48-fe74-4725-8c21-9e225e4c66fe12023-06-06
80425-0177-3EA - Each80425-0177878608ec-359c-4d4d-996c-df069331357c12023-04-07

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 12 of 12 · 225 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PregabalinPREGABALINProficient Rx LPa0f2b8af-0a04-4db0-adb3-d9d9369223d92022-04-01Warnings, Adverse reactionsExact identifier
application number: ANDA208677
rxcui: 483440
unii: 55JG375S6M
PREGABALINPREGABALINAsclemed USA, Inc.69b8a843-a3a8-4d76-8418-f482886250302020-06-25Warnings, Adverse reactionsExact identifier
rxcui: 483440
rxcui: 483444
rxcui: 483442
rxcui: 577127
rxcui: 483448
rxcui: 483438
rxcui: 483450
rxcui: 483446
unii: 55JG375S6M
LyricaPREGABALINParke-Davis Div of Pfizer Inc60185c88-ecfd-46f9-adb9-b97c6b00a5532020-06-15Warnings, Adverse reactionsExact identifier
rxcui: 483440
rxcui: 483444
rxcui: 483442
rxcui: 577127
rxcui: 483448
rxcui: 483438
rxcui: 483450
rxcui: 483446
unii: 55JG375S6M
PREGABALINPREGABALINProficient Rx LP4624c58f-8f77-48fa-be0f-fca4010cc8ae2019-10-01Warnings, Adverse reactionsExact identifier
rxcui: 483438
unii: 55JG375S6M
PREGABALINPREGABALINProficient Rx LP6022939f-92a8-4cb4-9f04-f237a4d73f6f2019-10-01Warnings, Adverse reactionsExact identifier
rxcui: 483450
unii: 55JG375S6M

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.